Cleared Traditional

HAND PACK (K914934) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914934 · Westmark Hospital Supplies · Gastroenterology & Urology device
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Jan 1993
Decision
444d
Days
Class 2
Risk

K914934 is an FDA 510(k) clearance for the HAND PACK. Classified as Rongeur, Cystoscopic, Hot (product code KDO), Class II - Special Controls.

Submitted by Westmark Hospital Supplies (Grand Rapids, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Westmark Hospital Supplies devices

Submission Details

510(k) Number K914934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 04, 1991
Decision Date January 21, 1993
Days to Decision 444 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 130d · This submission: 444d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDO Rongeur, Cystoscopic, Hot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.